Ventral Hernia, Ventral Hernia Repair, Postoperative Pain
Conditions
Keywords
ventral hernia, complex abdominal wall hernia, ventral hernia repair, postoperative pain control
Brief summary
This study is comparing two ways to manage pain after a major hernia repair surgery called "transversus abdominis release." One method uses an epidural, a small tube placed in the back that delivers pain medicine directly around the spine. The other method avoids the epidural and instead uses a combination of non-opioid pain medicines, along with an injection of numbing medicine into the abdominal wall during surgery. Patients who still have pain that is hard to control with either method will be given rescue pain medicine through an intravenous (IV) pump. Researchers want to learn which method controls pain better and results in patients using fewer opioid pain medicines after surgery. Participants will be randomly assigned (like a coin flip) to one of the two pain control methods. Pain levels and medication use will be tracked during the hospital stay, and participants will be contacted 30 days after surgery to check on recovery and any side effects.
Interventions
DRUGCyclobenzaprine
Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
PROCEDUREtransversus abdominis plane block
Regional anesthetic technique performed intraoperatively by the surgeon, injecting local anesthetic into the transversus abdominis plane of the abdominal wall, as part of the opioid-sparing multimodal analgesia protocol.
DRUGBupivicaine
Local anesthetic administered via thoracic epidural catheter, both as an intraoperative bolus and as part of a standardized postoperative continuous infusion combined with fentanyl, discontinued on postoperative day 3.
DRUGFentanyl
Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.
DEVICEThoracic epidural analgesia
Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.
DRUGHydromorphone
Opioid administered intravenously via patient-controlled analgesia (PCA) as rescue therapy for participants in either study arm who have inadequate pain control with their assigned analgesia protocol.
DRUGAcetaminophen
Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
DRUGKetorolac
Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
DRUGmagnesium sulfate
Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.
DRUGTramadol
Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
DRUGGabapentin
Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients ≥18 years old * Symptomatic incisional ventral or parastomal hernias * Planned transversus abdominis release * Ability to provide informed consent
Exclusion criteria
* Contraindications to epidural placement * Chronic pre-operative opioid use, defined as daily opioid use for 30-days prior to surgery * Allergy or intolerance to study medications * Age greater than 80 years * Impaired renal function - defined as creatinine clearance or estimated GFR of \<60ml/min * Planned ICU admissions with post-operative intubation * Urgent or emergent presentations * Adults unable to consent * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Postoperative Pain Scores | Postoperative Day 1 through Postoperative Day 4 | Postoperative pain will be measured using the Numeric Rating Scale (NRS, 0-10) at standardized 6-hour intervals over the first four postoperative days. The area under the curve of these serial measurements will be calculated to reflect cumulative postoperative pain burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Opioid Consumption | Through hospital discharge, an average of 5 days | Total opioid consumption during hospitalization, measured in oral morphine milligram equivalents (MME). For patients receiving epidural analgesia, neuraxial opioid use will be quantified and reported separately from oral/intravenous MME. |
| Length of Hospital Stay | Through hospital discharge, an average of 5 days | Total number of days from surgery to hospital discharge. |
| Incidence of Postoperative Ileus | Through hospital discharge, an average of 5 days | Postoperative ileus, defined as the requirement for nasogastric tube decompression. |
| Incidence of Epidural-Related Complications | Through hospital discharge, an average of 5 days | Hypotension (defined as a drop in systolic blood pressure or mean arterial pressure of more than 20% from baseline) and urinary retention requiring Foley catheter reinsertion. |
| Patient Satisfaction with Pain Management (Binary) | At hospital discharge | Patient satisfaction with postoperative pain management, assessed prior to discharge using a binary (yes/no) question. |
| 30-Day Postoperative Complications | 30 days (± 15 days) postoperatively | Incidence of wound complications, respiratory complications, hospital readmission, reoperation, and hernia recurrence, assessed as part of standard of care data collection. |
| 30-Day Postoperative Opioid Prescribing and Consumption | 30 days (± 15 days) postoperatively | Number and dose of opioids prescribed, and total opioids consumed, in the 30 days following surgery |
| Patient Satisfaction with Pain Management (Numeric Scale) | At hospital discharge | Patient satisfaction with postoperative pain management, assessed prior to discharge using a 1-10 numeric satisfaction scale, with higher scores indicating greater satisfaction. |
| Daily Average Numeric Rating Scale Pain Score | Postoperative Day 1 through Postoperative Day 4 | Average Numeric Rating Scale (NRS) pain score calculated for each of the first four postoperative days, on a scale of 1-10, with 0 meaning no pain and 10 being the worst pain imaginable |
Countries
United States
Contacts
CONTACTNancy Ly, MD
Outcome results
None listed